Reported Jul 29, 2015 · Terminated
Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC:…
Wockhardt USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Wockhardt Usa Inc. · 20 Waterview Blvd Ste 3 · Parsippany, NJ · 07054-1271
Is this the product you have?
- Famotodine Tablets, USP, 20 mg Tablets
- Packaged in A) 30 Count Bottles (NDC64679-936-01)
- B) 100 Count Bottles(NDC64679-936-02)
- and C) 1000 Count Bottles (NDC64679-936-03), Rx only
- Manufactured byWockhardt Limited, Mumbai, India
- Distributed byWockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
- Lot codes and dates
62 of 62 products
Products covered by this recall # Product as published 1 LM10708, Expiry: 4/30/2015 2 Lot #: LM10859, Expiry: 5/31/2015 3 Lot #: LM11200, Expiry: 7/31/2015 4 Lot #: LM11679, Expiry: 9/30/2015 5 Lot #: LN10465, Expiry: 1/31/2016 6 Lot #: LN10750, Expiry: 3/31/2016 7 Lot #: LN11385, Expiry: 9/30/2016. B) Lot #: LM10709, Expiry: 4/30/2015 8 Lot #: LM10719, Expiry: 4/30/2015 9 Lot #: LM10721, Expiry: 4/30/2015 10 Lot #: LM10827, Expiry: 5/31/2015 11 Lot #: LM10828, Expiry: 5/31/2015 12 Lot #: LM10912, Expiry: 5/31/2015, Lot #: LM11205, Expiry: 7/31/2015 13 Lot #: LM11206, Expiry: 7/31/2015, Lot #: LM11239. Expiry: 7/31/2015 14 Lot #: LM11680, Expiry: 9/30/2015 15 Lot #: LM11822, Expiry: 10/31/2015 16 Lot #: LM11993, Expiry: 10/31/2015 17 Lot #: LN10114, Expiry: 12/31/2015 18 Lot #: LN10115, Expiry: 12/31/2015 19 Lot #: LN10695, Expiry: 3/31/2016 20 Lot #: LN10696, Expiry: 3/31/2016 - Amount recalled
- A) 69,008 Bottles, B) 399,730 Bottles, and C) 58,116 Bottles.
This recall covers 35 products
The agency filed one notice per product. You are reading one of them; the other 34 are below.
22 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
CGMP Deviations: Firm did not adequately investigate customer complaints.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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